Director/Senior Director, Regulatory Affairs

This position is responsible for the development and implementation of regulatory strategies and FDA regulated quality assurance activities for pipeline programs to ensure compliance with applicable regulations (GMP, GLP, and GCP). This involves proactively identifying, assessing and mitigating regulatory risks to the plans.  Will share regulatory knowledge and insight that impact product and policy development by interpreting policy and industry trends, advising on agency interactions, and sharing regulatory lessons learned in order to help users navigate policy issues and minimize regulatory risks. 

Essential Functions

• Develop, implement and maintain regulatory and quality assurance strategies and activities for AnaptysBio’s pipeline      programs.
• Serve as the FDA contact, leading creative and constructive interactions with regulatory agencies to effectively negotiate regulatory agreements, and to ensure that all projects have clearly defined regulatory paths and milestones. 
• Manage regulatory project plans and timelines for projects in accordance with project, department and corporate goals.
• Keep abreast of all pertinent laws, regulations and guidance; develop aligned recommendations for regional regulatory strategies and implementation activities and share insights that impact product and policy development on a global level 
• Develop and implement regulatory affairs practices and policies in compliance with quality systems, and to assure adherence to global and regional requirements, and SOPs.
• Review protocols, reports and summary documents (clinical, pharmacology & toxicology) for adherence to regulatory guidelines, strategies, and commitments. 
• Manage the assembly, support the review, and submission of, regulatory documentation such as INDs, CTAs, responses, etc. ensuring consistency/completeness/adherence to standards for all regulatory submissions. 
• Ensure the quality, content and format of regulatory submissions and for communication and teamwork with project team members.  
• Advise the project teams on applicable regulatory guidances and other appropriate product regulations that impact the development of product candidates.
• Interpret and advise the project team on the application of industry regulations, the FDA review process and international regulatory requirements.
• Support the implementation of departmental Standard Operating Procedures (SOPs) to ensure compliance with applicable domestic and foreign regulations and industry guidance (cGMP, GCP, GLP, etc).
• Host for regulatory and quality agency inspections of AnaptysBio, and associated CMOs/CROs; translate findings into action items as applicable.
• Manage the application of the Quality System programs, including but not limited to conducting internal  and external audits, reviews of study protocols, analytical test methods, method validation protocols and reports, instrument qualifications, software validations and standard operating procedures, to ensure quality and compliance with GLP and other applicable regulations and departmental procedures 

Education & Experience: 

• Theoretical knowledge typically achieved through a related four-year college experience, such as a Bachelor’s degree in Science or a related discipline.
• 15 years of experience in regulatory affairs and quality assurance. Strong CMC experience and international experience is a plus.
• Experience with Phase 1 through marketing application submission process. 
• Successful contribution to a major regulatory approval at a global or regional level preferred. 
• Experience in organizing and running successful FDA meetings.
• Experience with multiple regulatory disciplines (CMC, clinical, labeling, etc.).
• Demonstrated ability in leading the development of sound and effective regulatory strategies.  Identify and communicate potential risks associated with strategy scenarios.  
• Demonstrated leadership ability in team/department settings.
• Proven leadership and program management experience. 
• Demonstrated advanced skills in the hosting of agency inspections, and in conducting own of audits and inspection, and translating findings into CAPAs that mitigate risks.

Knowledge Requirements: 

• A scientific and clinical understanding of the regulatory and quality assurance sciences.
• Demonstrated understanding of regulations and guidelines governing drug development (particularly clinical drug development) including ability to apply these to overall strategic drug development. 
• Comprehensive and contemporary knowledge of and experience with cGMP and GLP requirements, familiarity with GCP requirements and FDA and EU regulations and applicable regulatory guidance documents
• Knowledge of and experience with both US and international regulatory filings.
• Experience with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Adobe, and Internet Explorer.

Personal Competencies: 

• Effective communication and interpersonal skills, with the ability to effectively influence actions and opinions of others, present results and analysis to colleagues at all levels, including scientific/medical and management. Speaks clearly and persuasively in positive or negative situations; Listens and obtains clarification; Responds well to questions.
• Demonstrated group presentation skills; Participates in meetings. Ability to respond effectively to the most sensitive inquiries or complaints. 
• Ability to work effectively in as a team player in a complex, changing environment, intensely committed to success and getting the job done well, with the additional ability of being able to build morale and group commitments to goals and objectives;
• Ability to work productively in a matrix team environment, as well as take ownership of multiple projects.
• Ability to define issues, collect, and analyze complex data, and draw valid conclusions. 
• Ability to identify and resolve problems in a timely manner by identifying alternative solutions
• Ability to develop strategies to achieve organizational goals; demonstrates an understanding of organization's situation and goals; analyzes market and competition; identifies threats and opportunities; adapts strategy to changing conditions.
• Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
• Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.

Other Information

• Position may require occasional evening and/or weekend commitment
• Position will require domestic and international travel